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Back to 2016 Annual Meeting


Adverse Effects of Testosterone Replacement Therapy for Men
Alexander P. Cole, MD1, Julian Hanske, MD2, Wei Jiang, MS3, Jesse D. Sammon, DO4, Quoc-Dien Trinh, MD1.
1Harvard Medical School, Brigham and Womens Hospital, Boston, MA, USA, 2Department of Urology, Marien Hospital Ruhr-University Bochm, Herne, Germany, 3Harvard Medical School, Center for Surgery and Public Health, Boston, MA, USA, 4Vattikuti Urology Institute, Henry Ford Health System, Detroit, MI, USA.

Introduction: The past decades have thus seen dramatic increase in the use of testosterone replacement therapy (TRT) for middle-aged men with testosterone levels below reference ranges for young men. While TRT may increase libido, reduce adiposity, increase muscle mass and improve bone density, some high profile studies suggest increased risk of cardiovascular, thromboembolic and prostate related complications. Much of this research was performed with older populations that are not representative of men most commonly using TRT in community settings. Given this uncertainty, we designed a study using a large national database to assess rates of prostate cancer, hepatotoxicity, thromboembolic and cardiovascular events, and obstructive sleep apnea (OSA) in a sample of adult men treated with TRT.
Materials and Methods: We utilized the TRICARE military database. TRICARE is the health care program of active members of the US Uniformed Services, retirees, and their relatives. It incorporates men using direct care (salaried military physicians) as well as purchased care (in a fee-for-service system similar to private insurance). We identified 36,882 men age 18-65, diagnosed with hypogonadism who received at least one dose of TRT between 2006-2010. We defined a matched cohort of controls who did not receive TRT. We compared event free survival and absolute risk of above complications between men using TRT and matched controls.
Results: As shown in Figure 1 there was no significant difference in event free survival for prostate cancer (p=0.255), hepatotoxic (p=0.345), and thromboembolic events (p=0.239). Relative to controls, patients treated with TRT had better cardiovascular event free survival (p=0.004) but were more likely to develop OSA (p<0.001). The 2-year absolute risk of prostate
1
cancer was 0.93% in the TRT cohort and 1.0% in controls (95%CI: 0.6% - 1.4% vs. 0.7% - 1.4%). The risk of cardiovascular events was 6.0% in TRT group versus 7.0% in controls (95% CI: 4.9% - 6.7% vs. 6.2% - 8.0%). The only significant difference in 2-year absolute risk was OSA, which occurred in 1.7% of the TRT men compared to 1.2% of controls (95% CI: 1.56%-1.84% vs. 1.1%-1.4%).
Conclusion: In contrast to recent high profile trials assessing TRT use in relatively elderly (age >65) and comorbid populations, in our cohort of younger and generally healthy men using TRT in military and community based settings, there was no significant difference in the risk of prostate cancer, hepatotoxicity, thromboembolic or cardiovascular events. Prior studies performed in older and more comorbid populations suggesting adverse effects may be less generalizable to healthy, younger men using these medications in a community setting.


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