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Testosterone deficiency (TD), also called hypogonadism, is a relatively common condition, with an estimated prevalence of 2.4 million among US men 40–69 years old.1 Decline in testosterone, shown to occur with aging, may negatively affect health and quality of life.2–5 TD has been associated with frailty as well as age-related declines in bone mineral density, muscle mass and strength, physical function, and sexual function, and with metabolic changes involving abdominal obesity, metabolic syndrome progressing to type 2 diabetes, insulin resistance, impaired glucose tolerance, negative changes in low-density lipoprotein (LDL) cholesterol, low-density lipoprotein/high-density lipoprotein (HDL) cholesterol ratios, and depression.5–13 Studies focused specifically on men ≥64 years old have shown associations between low testosterone and lower muscle mass, strength, and physical performance.14–17 The treatment of TD in older men has generated some debate. Current Endocrine Society clinical practice guidelines recommend offering testosterone replacement therapy (TRT) on an individualized basis to men with repeatedly measured low testosterone levels and clinically significant signs of hypogonadism; however, a consensus has not been reached on the serum testosterone levels below which TRT is recommended (ie, below 280–300 ng/dL [9.7–10.4 nmol/L], the lower limit of normal for healthy young men, or below a more stringent 200 ng/dL [6.9 nmol/L]).6 This is further complicated in older men with TD (eg, late onset hypogonadism) since it is unclear what “normal” testosterone levels may be for this population and when TRT should be used, especially in a frail elderly population.18 Furthermore, safety concerns regarding prostate cancer and cardiovascular events remain important topics in treating older men with TD. It may be for these reasons that TD is often underdiagnosed and undertreated in middle-aged and older men.9,19 Additionally, symptoms of TD may be dismissed as signs of aging because they develop slowly and overlap with other common disorders in older men, and patients can have low-normal or borderline testosterone levels, but still show symptoms due to variations in androgen sensitivity.18 The ongoing questions regarding TRT in older men with TD may be due to a lack of naturalistic data on whether and how men ≥65 years old are treated for TD in clinical practice settings compared with middle-aged men. To address these questions, we report on data from men enrolled in the Testim Registry in the United States (TRiUS), the first prospective, observational cohort registry of hypogonadal men on TRT. TRiUS enrolled a large sample of TD patients from a variety of clinical settings in the United States with the objective of quantifying symptoms and comorbidities of these patients and their response to Testim® 1% gel (Auxilium Pharmaceuticals, Malvern, PA), a topical testosterone gel formulation for TRT. This analysis compares TRiUS baseline and 12-month follow-up data for hypogonadal men ≥65 vs

Background Recent evidence suggests that there may be a bidirectional, physiological link between hypogonadism and metabolic syndrome (MetS), and testosterone replacement therapy (TRT) has been shown to improve some symptoms of MetS in small patient populations. We examined the effect of 12 months of TRT on MetS components in a large cohort of hypogonadal men. Methods Data were obtained from TRiUS (Testim® Registry in the United States), a 12-month, multicenter, prospective observational registry (N = 849) of hypogonadal men prescribed Testim 1% testosterone gel (5-10 g/day). Data analyzed included age, total testosterone (TT), free testosterone (FT), sex hormone-binding globulin (SHBG), and MetS components: waist circumference, blood pressure, fasting blood glucose, plasma triglycerides, and HDL cholesterol. Results Of evaluable patients (581/849) at baseline, 37% were MetS+ (n = 213) and 63% were MetS- (n = 368). MetS+ patients had significantly lower TT (p < 0.0001) and SHBG (p = 0.01) levels. Patients with the lowest quartile TT levels ( Conclusion Hypogonadal MetS+ patients were more likely than their MetS- counterparts to have lower baseline TT levels and present with more comorbid conditions. MetS+ patients and those in the lowest TT quartile showed improvement in some metabolic syndrome components after 12 months of TRT. While it is currently unclear if further cardiometabolic benefit can be seen with longer TRT use in this population, testing for low testosterone may be warranted in MetS+ men with hypogonadal symptoms.