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Sandy Srinivas, MD


HERO and the Heart: How Cardiovascular Agents Impact the Use of Relugolix in Advanced Prostate Cancer

By: Celeste L. Dixon
Posted: Tuesday, March 14, 2023

In men with prostate cancer, who may be likelier to have cardiovascular risk factors and to be taking heart-related medications than other men, cardiovascular events rather than cancer are the leading cause of death. Of note, the risk of major cardiovascular and cerebrovascular events may be significantly lower when using gonadotropin-releasing hormone antagonists such as relugolix, compared with luteinizing hormone-releasing hormone agonists such as leuprolide. In the phase III HERO study, Fred Saad, MD, of the University of Montreal Hospital Centre, and colleagues reported the overall incidence of major adverse cardiac events was 54% lower in men treated with relugolix versus leuprolide. But what is the impact of taking concomitant cardiovascular agents?

The team’s subgroup analysis of HERO has now shown that relugolix safely and effectively suppressed testosterone when given along with cardiovascular agents, with results consistent with those of the overall population. The data were presented during the Journal of the Advanced Practitioner in Oncology conference JADPRO Live (Abstract JL1017E).

A total of 934 men were randomly assigned on a 2:1 basis to receive oral relugolix or leuprolide injections for 48 weeks; the arms were well matched for age, metastatic disease, history of major adverse cardiovascular events, and other cardiovascular risk factors. The subgroup’s analysis included men who received antihypertensives, antithrombotics, or lipid-modifying therapies; overall, in HERO, antihypertensives, antithrombotics, and lipid-modifying agents were used by 52.7%, 39.1%, and 39.6% of men, respectively.

Assessments of sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks—HERO’s primary efficacy endpoint—showed that in each subgroup, point estimates for sustained castration rates were consistent with the relugolix and leuprolide estimates observed in the overall population. Regarding safety, the incidence and types of adverse events were generally similar among men who received antihypertensives, antithrombotics, and lipid-modifying agents. The team noted further, however, that “men on concomitant antithrombotics had a higher incidence of serious adverse events versus the overall population (13.2%), with 23.3% and 24.8% in the relugolix and leuprolide groups, respectively.”

Disclosure: The study authors’ disclosure information can be found at

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