Objectives Testosterone therapy (TTh) is the main treatment for elderly men with hypogonadism. No evidence of the long-term effectiveness of TTh on renal function is reported to date. Methods In this study, we evaluated the long-term TTh of testosterone undecanoate (TU) administration on renal function parameters in 496 symptomatic hypogonadal men, with T levels ≤350 ng/dL. The treatment group (T-group) consisted of 312 patients and obtained TU 1000 mg for 12 weeks followed by 6-week intervals and for up to 8 years. The remaining 184 hypogonadal men, who opted against TTh, served as a control group (C-group). The two groups were similar in criteria prior to treatment. We evaluated renal function by calculating serum creatinine, urea, uric acid, and glomerular filtration rate (GFR) according to Mayo Clinic guidelines for 8 years. This study obeys the ethical guidelines of German medical association according to Section 15 of the Professional Code, document for AY- Ref. EK/CH/AU signed on Jun 2015. Results During the study period, the T-group exhibited lower levels of urea (47.0 ± 11.8 to 34.0 ± 13.9 mg/dL), uric acid (6.57 ± 1.2 to 5.49 ± 1.5 mg/dL), serum creatinine (0.90 ± 0.10 to 1.12 ± 0.9 mg/dL), and higher-level in GFR (87.0 ± 12.9 to 98.0 ± 8.0 mL/min/1.73 m 2 ), which were significant. Alternatively, the C-group exhibited an increase in their serum creatinine (1.16 ± 0.31 to 1.19 ± 0.58 mg/dL), an increase in uric acid (5.54 ± 1.2 to 5.44 ± 1.7 mg/dL), and a decrease in GFR (92.0 ± 20.1 to 87.0 ± 26.1 mL/min/1.73 m 2 ). A total of 25 deaths (7.8%) was recorded in the T-group, among them 11 (44%) were cardiovascular. On the other hand, 28 patients (15.2%) died in C-group and all deaths (100%) were found to cardiovascular causes. Conclusion The results suggest that long-term TTh could improve renal function in hypogonadal men comparing to slight deterioration observed in patients without intervention. In addition to reduce mortality in cardiovascular patients, almost to the half.
Objectives : To report the association between testosterone treatment in hypogonadal men with hepatic steatosis, non-alcoholic fatty liver disease and cardiovascular disease (CVD). Methods: A prospective study was conducted to assess the physiological and functional performance of the long-term effects of testosterone undecanoate treatment on hepatic steatosis in 496 hypogonadal men. Two groups were studied, the treatment group (T-group) of 312 patients treated with TU 1000 mg every 12 weeks and followed for 8 years, and an untreated control group (C-group) of 184 patients. We evaluated liver functions and Fatty Liver Index (FLI) according to Mayo Clinic parameters and guidelines. Results: The T-group showed a decrease in the FLI (from a mean [SD] of 83.70 [12.15] to 67.12 [19.21]), bilirubin (from a mean [SD] of 1.69 [4.21] to 1.31 [1.91] mg/dL), triglycerides (from a mean [SD] of 254.87 [92.99] to 213.37 [66.91] mg/dL), and gamma-glutamyl-transferase (from a mean [SD] of 39.45 [11.51] to 29.11 [7.68] U/L) over the duration of the study. Other parameters were also reduced in the T-group such as body mass index (from a mean [SD] of 31.59 [4.51] to 29.50 [3.84] kg/m 2 ) and waist circumference (from a mean [SD] of 107.51 [9.95] to 101.86 [9.28] cm). A total of 25 deaths (7.8%) were recorded in the T-group, among them, 11 (44%) were related to CVD. While in the C-group 28 deaths (15.2%) were recorded and all the reported deaths (100%) were related to CVD. Conclusions: The findings suggest that long-term testosterone therapy in hypogonadal men improves liver function. While, the physiological and functional improvements in the liver may be associated with a decrease in CVD-related mortality. Abbreviations ALT: alanine transaminase; AR: androgen receptor; AST: aspartate transaminase; BMI: body mass index; CVD: cardiovascular disease; FLI: Fatty Liver Index; γ-GT: gamma-glutamyl-transferase; MetS: metabolic syndrome; LDL: low-density lipoprotein; NAFLD: non-alcoholic fatty liver disease; RCT: randomised controlled trial; T2DM: type II diabetes mellitus; TT: total testosterone; TTh: testosterone therapy; TU: testosterone undecanoate; WC: waist circumference
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