Ann Arbor, MI—Pharmacists should be aware of new research linking two common oral medications for advanced prostate cancer to serious metabolic or cardiovascular (CV) issues.

A report in the Journal of the National Cancer Institute suggested that among men who had or were receiving hormone therapy, those who were also prescribed either of the two most common oral medications for advanced prostate cancer showed a higher risk of serious metabolic or CV issues compared with patients receiving only hormone therapy.

Michigan Medicine researchers from the University of Michigan reported that patients taking abiraterone had 1.77 times the risk of being admitted to the emergency room or the hospital because of diabetes, hypertension, or heart disease and that those receiving enzalutamide had 1.22 times the risk of those same problems.

There was some difference between the two groups, however. Compared with patients not receiving abiraterone, those taking abiraterone were also more likely to need an outpatient visit with their physician because of endocrinological or CV health conditions, but that was not the case for patients taking enzalutamide.

The report raises a disturbing concern: Abiraterone and enzalutamide were both found to be relatively safe in clinical trials, in which most of the participants were younger than the patients in this study, who were older and on Medicare.

"Patients enrolled in clinical trials tend to be highly selected and often times do not reflect the patient population in day-to-day practice," explained first author Lillian Y. Lai, MD, MS, a National Institutes of Health T32 urologic oncology research fellow at Michigan Medicine. "Trial participants also undergo stringent safety evaluations that some of our patients do not have access to. By studying adverse events in real-life settings, we can better understand the risks of these life-prolonging cancer treatments and help clinicians and patients make informed decisions regarding treatment."

Men with advanced prostate cancer were identified in a 20% sample of the 2010-to-2017 national Medicare claims. Specifically, results indicated that, compared with men not receiving abiraterone, men receiving abiraterone were at increased risk of both a major composite adverse event (hazard ratio [HR], 1.77; 95% CI, 1.53-2.05; P <.001) and a minor composite adverse event (HR, 1.24; 95% CI, 1.05-1.47; P = .01). Compared with men not receiving enzalutamide, men receiving enzalutamide were at increased risk of a major composite adverse event (HR,1.22; 95% CI, 1.01-1.48; P = .04) but not a minor composite adverse event (HR, 1.04; 95% CI, 0.83-1.30; P = .75).

"Careful monitoring and management of men on abiraterone or enzalutamide through team-based approaches are critical," the authors emphasized.

As a way to manage the higher risks, Dr. Lai and her fellow authors recommended team-based care involving primary care physicians for patients with advanced prostate cancer.

"With continued expansion of the indications for abiraterone and enzalutamide to earlier stages of the disease, increasing numbers of men will be receiving these therapies for longer periods of time," Dr. Lai cautioned. "This will potentially amplify the scope of men affected and increase the magnitude of the risks of adverse events, making careful attention to management of these issues crucial."

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