Testosterone replacement therapy is safe for use in treating hypogonadism in men

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SAT 554-583-Male Reproductive Endocrinology & Case Reports
Clinical
Saturday, June 15, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SAT-568
Jonathan C Brooke*1, Preethi Rao2, Debbie Walter1, Amrita Dhutia1, David McLaren1, Muraleedharan Vakkat1 and Thomas Hugh Jones2
1University of Sheffield, Sheffield, United Kingdom, 2Barnsley Hospital NHS Foundation Trust, Barnsley, United Kingdom
Testosterone replacement therapy (TRT) has beneficial effects on CVD risk factors including insulin resistance, dyslipidaemia, obesity, hypertension and pro-atherogenic states. Nevertheless, the use of TRT remains controversial as quality evidence to evaluate its safety is somewhat lacking.

A long-term retrospective analysis of 505 hypogonadal men (mean age 59.9+14.4years; mean baseline testosterone 7.09+2.53nmol/l; 46.1% with diabetes mellitus) receiving physiological TRT (82.8% testosterone gels) for up to 27 years (mean 4.94 years) in normal clinical practice was carried out to evaluate the safety of TRT. This represented over 2467 patient-years of TRT. Levels of testosterone, estradiol and PSA were monitored at 3, 6 and 12 months and yearly thereafter. BMI, waist circumference, blood pressure (BP), hemoglobin (Hb), hematocrit (HCT), lipid profile and liver function tests were also recorded. Data from the most recent clinic appointments represented the primary endpoint. Hospital admissions, major adverse cardiovascular events (MACEs), mortalities and prostate-related outcomes were recorded.

TRT was associated with an increase in HCT by 0.03 (0.45 vs. 0.42, p<0.001) at the primary endpoint. PSA rose modestly by 0.31g/l (1.37 vs. 1.06, p=0.001). By the primary endpoint PSA levels were comparable to those of age-matched eugonadal males and were not grossly elevated. Polycythaemia (HCT >0.52) developed in 34 out of 505 patients. 6 new cases of BPH and 5 new prostate carcinomas were diagnosed, no more than were expected in this population which included aging individuals. 8 patients were newly diagnosed with diabetes mellitus during follow-up and 38 MACEs (8 MIs, 12 angina, 5 TIAs, 5 CVAs, 7 CABGs, 1 congestive cardiac failure) were identified. Over the course of the study there were 89 hospital admissions and 6 mortalities. These rates are no higher than expected rates in this morbid population.

This is the largest and most comprehensive study of TRT safety to date, representing over 2467 patient-years of TRT. TRT was not associated with increased rates of prostate carcinoma, MACEs or mortality. TRT was also associated with beneficial effects on traditional cardiovascular risk factors (significantly lowering levels of lipids, total cholesterol, LDL cholesterol and HbA1C), thus supporting the cardioprotective role of physiological testosterone levels.

Disclosure: THJ: Consultant, Bayer Healthcare, Researcher, Bayer Healthcare, Speaker, Bayer Healthcare, Consultant, Eli Lilly & Company, Consultant, Pro Strakan, Researcher, Pro Strakan, Speaker, Pro Strakan, Consultant, Merck, Consultant, Clarus. Nothing to Disclose: JCB, PR, DW, AD, DM, MV

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm