MedicalResearch.com Interview with:
T. Craig Cheetham, PharmD, MS
Southern California Permanente Medical Group
Department of Research & Evaluation
Pasadena, CA 91101
MedicalResearch.com: What is the background for this study?
Response: Concerns have been raised about the cardiovascular safety of testosterone replacement therapy. Patient selection criteria may have been a factor in the findings from studies reporting an increased cardiovascular risk with testosterone replacement therapy. Many men who were receiving testosterone replacement therapy don’t fall into the categories of ‘frail elderly’ or ‘high cardiovascular risk’. We therefore studied testosterone replacement therapy in a population of androgen deficient men within Kaiser Permanente Northern and Southern California.
MedicalResearch.com: What are the main findings?
Response: Our study found no indication of an increased risk for cardiovascular events in androgen deficient men receiving testosterone replacement therapy.
The study evaluated 44,335 male patients who had been diagnosed with androgen deficiency or had a documented low morning serum testosterone level. Of these, 8,808 men were treated with testosterone replacement therapy while 35,527 were never dispensed testosterone. Of the men who never received testosterone, 10.2 percent had a heart attack or stroke during the study period while 8.2 percent had a heart attack or stroke in the group that received testosterone replacement therapy. The adjusted hazard ratio (HR) was 0.67, 95% confidence interval (CI): 0.62-0.73.
MedicalResearch.com: What should readers take away from your report?
Response: Our study found no indication of an increased risk for cardiovascular events for men with androgen deficiency being treated with testosterone replacement therapy.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: There are several questions that remain to be answered. Our study was not designed to determine the effects of testosterone dosage or duration of therapy and these remain unanswered questions. One of the interesting findings from our study was that patients with high serum testosterone levels at baseline (> 400 ng/ml) were at a higher risk of cardiovascular events (note: the total number of patients with baseline testosterone > 400ng/ml was very small in our study). I don’t believe this has been reported before and deserves further investigation. Lastly, more research should be done to answer questions regarding the safety of testosterone replacement therapy in men with high cardiovascular risk.
MedicalResearch.com: Is there anything else you would like to add?
Response: I recently retired from Kaiser Permanent (December 2016) after 24 years. I have taken a position as a Visiting Scholar at the Western University School of Pharmacy.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Cheetham TC, An J, Jacobsen SJ, Niu F, Sidney S, Quesenberry CP, VanDenEeden SK. Association of Testosterone Replacement With Cardiovascular Outcomes Among Men With Androgen Deficiency. JAMA Intern Med. Published online February 21, 2017. doi:10.1001/jamainternmed.2016.9546
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