Having just posted a blog on the FDA approval of Orgovyx (relugolix), I mentioned being disappointed that the FDA stated there was a risk of cardiac electrical irregularities. While this is true, I believe it’s important for me to point out the findings of the Phase 3 HERO trial of relugolix vs. leuprolide, which clearly states there was a significant reduction in the incidence of major adverse cardiovascular events of 2.9% in the relugolix group vs. 6.2% in the leuprolide group (hazard ratio, 0.46).
Another important advantage of oral relugolix was the higher percentage of patients with testosterone recovery to the normal range 90 days after discontinuation of treatment, which was 54% for the relugolix group vs. just 3% for the leuprolide group. This is very important for men who hope to explore IADT, or Intermittent Androgen Deprivation Therapy.
You can read all the findings in the Phase 3 HERO trial here –The full text is available to everyone: https://www.nejm.org/doi/10.1056/NEJMoa2004325