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2.  Testosterone replacement therapy among elderly males: the Testim Registry in the US (TRiUS) 
Background:
Testosterone levels naturally decline with age in men, often resulting in testosterone deficiency (hypogonadism). However, few studies have examined hypogonadal characteristics and treatment in older (≥65 years) men.
Objective:
To compare data at baseline and after 12 months of testosterone replacement therapy (TRT) in hypogonadal men ≥65 vs <65 years old. Data for participants 65–74 vs ≥75 years old were also compared.
Methods:
Data were from TRiUS (Testim Registry in the United States), which enrolled 849 hypogonadal men treated with Testim® 1% (50–100 mg testosterone gel/day) for the first time. Anthropometric, laboratory, and clinical measures were taken at baseline and 12 months, including primary outcomes of total testosterone (TT), free testosterone (FT), and prostate-specific antigen (PSA) levels. Comparisons of parameters were made using Fisher’s exact test or analysis of variance. Nonparametric Spearman’s ρ and first-order partial correlation coefficients adjusted for the effect of age were used to examine bivariate correlations among parameters.
Results:
Of the registry participants at baseline with available age information, 16% (133/845) were ≥65 years old. They were similar to men <65 years old in the duration of hypogonad-ism prior to enrollment (∼1 year), TT and FT levels at baseline, TT and FT levels at 12-month follow-up, and in reported compliance with treatment. Older patients were more likely to receive lower doses of TRT. PSA levels did not statistically differ between groups after 12 months of TRT (2.18 ± 2.18 ng/mL for ≥65 vs 1.14 ± 0.84 ng/mL for <65 years old, P = 0.1). Baseline values for the >75-year-old subcohort were not significantly different from subcohorts aged 65–74 years and <65 years.
Conclusion:
Hypogonadal men ≥65 years old showed significant benefit from TRT over 12 months, similar to that found for hypogonadal men <65 years old. TRT was well tolerated in older patients, successfully increased testosterone level regardless of age, and did not significantly increase PSA levels in older men.
doi:10.2147/CIA.S32036
PMCID: PMC3430096  PMID: 22956867
male hypogonadism; elderly; testosterone replacement therapy; testosterone gel; TRiUS registry; Testim
3.  Effect of 12 months of testosterone replacement therapy on metabolic syndrome components in hypogonadal men: data from the Testim Registry in the US (TRiUS) 
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 (<206 ng/dL [<7.1 nmol/L]) had a significantly increased risk of MetS+ classification vs those with highest quartile TT levels (≥331 ng/dL [≥11.5 nmol/L]) (odds ratio 2.66; 95% CI, 1.60 to 4.43). After 12 months of TRT, TT levels significantly increased in all patients (p < 0.005). Despite having similar TT levels after TRT, only MetS+ patients demonstrated significant decreases in waist circumference, fasting blood glucose levels, and blood pressure; lowest TT quartile patients demonstrated significant decreases in waist circumference and fasting blood glucose. Neither HDL cholesterol nor triglyceride levels changed significantly in either patient population.
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.
doi:10.1186/1472-6823-11-18
PMCID: PMC3217857  PMID: 22044661
Testosterone; metabolic syndrome; obesity; testosterone gel; testosterone replacement; TRiUS registry; Testim; hypogonadism; testosterone deficiency; fasting glucose
4.  Is hyperlipidemia or its treatment associated with erectile dysfunction? Subtitle: Results from the Boston Area Community Health (BACH) Survey 
The journal of sexual medicine  2009;6(5):1402-1413.
Introduction
Studies and reports suggest that both hyperlipidemia and its pharmacologic treatment may lead to an increased risk of erectile dysfunction (ED).
Aims
Our objectives were to examine the association between 1) treated hyperlipidemia and ED; 2) untreated hyperlipidemia and ED.
Methods
Data from 1,899 men aged 30–79 were used from the Boston Area Community Health Survey of community-dwelling residents of Boston, MA, collected during 2002–2005 using an in-person interview, self-administered questionnaires, and a venous blood draw.
Main Outcome Measures
ED was measured using the Short Form International Index of Erectile Function. A case of treated hyperlipidemia was defined by use of anti-lipemics in the past month, while untreated hyperlipidemia was serum total cholesterol ≥240 milligrams per deciliter with no anti-lipemic use. We estimated associations using odds ratios (ORs) and 95% confidence intervals (CIs) from multivariate logistic regression.
Results
Men with treated hyperlipidemia were older, had more comorbidities and used more medications compared to men with untreated hyperlipidemia or no hyperlipidemia. In multivariate models stratified by age and the presence of diabetes and/or cardiovascular disease (CVD), we saw no association between hyperlipidemia drug treatment and ED, except among younger men (<55) who had diabetes and/or CVD, where a strong association with an imprecise confidence interval was observed (OR=10.39, 95% CI: 3.25, 33.20). There was no significant positive association between untreated hyperlipidemia and ED in any multivariate model.
Conclusion
Lipid-lowering medications may be associated with ED among some men. The well-established benefits of lipid-lowering therapy should always be weighed against potential adverse effects.
doi:10.1111/j.1743-6109.2008.01207.x
PMCID: PMC3049259  PMID: 19210709

Results 1-4 (4)