Vilnius, Lithuania—A new population study is raising concerns that hormone therapy for prostate cancer increases the risk of cardiovascular disease (CVD)-related death, chiefly in older men who are most likely to be diagnosed with the cancer.

The results of the study, which involved more than 13,000 patients, were published in the peer-reviewed journal The Aging Male. Lithuanian researchers reported that they identified an elevated risk of death from CVD in men with prostate cancer who were treated with hormone-lowering drugs compared with those who were not.

The increased risks—most notably coronary heart disease and stroke—appeared during the second year after cancer diagnosis and were more serious with older age, according to the researchers.

"Hormone therapy is often used for patients with prostate cancer, but more research is now needed to gain a better understanding of the overall risks and benefits of this treatment," explained lead author Justinas Jonusas of the Lithuanian National Cancer Institute. "Our results suggest clinicians should consider risk reduction and mitigation strategies for cardiovascular disease when developing a treatment plan for men diagnosed with prostate cancer, particularly for older patients."

The study team sought to evaluate the risk of CVD mortality in the national cohort of patients diagnosed with prostate cancer and treated with androgen-deprivation therapy (ADT) compared with the ADT non-users. To do that, researchers conducted a retrospective cohort study of patients aged 40 to 79 years who were diagnosed with prostate cancer between January 1, 2012, and December 31, 2016, using the Lithuanian Cancer registry data. There were 13,343 prostate cancer patients included in the study who exclusively used gonadotropin-releasing hormone agonists. The primary outcome was defined as overall CVD death.

The results indicated a higher risk of CVD death in the cohort of patients treated with ADT compared with ADT non-users (hazard ratio [HR] 2.14, 95% CI 1.86-2.45, P <.001). "Moreover, there was an increased risk of death from ischemic heart disease and stroke (HR 1.42, 95% CI 1.16-1.73 and 1.70, 95% CI 1.18-2.45, respectively) among ADT users," the authors noted. "Finally, the risk of CVD-related mortality was highest in the 70-79 age group of ADT users (HR 4.78, 95% CI 3.79-6.04)."

That translated to:

• A more than twofold increase in the risk of death from CVD in men who had received hormone therapy.
• A higher risk of CVD-related death from the second year onward following a prostate cancer diagnosis.
• An almost fivefold higher risk in patients in the group aged 70 to 79 years who received hormone therapy compared with those who did not.

The researchers concluded that ADT usage is associated with increased CVD-related mortality risk in patients diagnosed with prostate cancer compared with ADT nonusers.

Background information in the study called ADT a "backbone therapy" for patients diagnosed with advanced, metastatic, and high-risk localized prostate cancer, pointing out that options include bilateral orchidectomy, gonadotropin-releasing hormone agonist (GnRH), and antagonist, with the agonist used most widely.

The authors also pointed to past studies on the association between cardiovascular-event incidence ratio and ADT.

"Prostate cancer is typically diagnosed in older men, over 65 years or older—and many of them will have already been diagnosed with cardiovascular disease," Mr. Jonusas said. "It is therefore concerning that we found such a tremendous increase in the risk of cardiovascular disease-related death in elderly males receiving hormone-lowering drugs. Consequently, we would like to express our notion that this group of patients should be screened for preexisting cardiovascular disease and their risk factors to minimize the risk of dying from these conditions."

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