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Positive effects of long-term treatment with testosterone undecanoate injections (TU) on renal function in hypogonadal men: real-life data from a prospective controlled registry Study

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Sources of Funding: none

Introduction

A registry was established to assess long-term effectiveness and safety of testosterone undecanoate injections (TU) in a urological setting in comparison to an untreated hypogonadal control group. Parameters related to renal function were measured to gain insight on effects of testosterone therapy (TTh) on renal function.

Methods

Observational, prospective, cumulative registry study in 505 men (age: 61.4 ± 9.7 years) with total testosterone (T) levels ≤350 ng/dL and symptoms of hypogonadism. 321 men received parenteral TU 1000 mg/12 weeks following an initial 6-week interval for up to 12 years (T-group). 184 men had opted against TTh and served as controls (CTRL). 8-year data were analyzed. Renal profile was assessed by (Creatinine, Urea, Uric acid and Glomerular filtration rate measured according to Mayo Clinic setting)

Results

Creatinine decreased from 1.14±0.18 to 1.07±0.8 mg/dL in the T-group and increased from 0.99±0.25 to 1.13±0.53 in CTRL._x000D_ Uric acid decreased from 6.8±1.5 to 5.5±1.6 mg/dL in the T-group (p<0.0001) and from 5.7±1.5 to 5.2±1.5 mg/dL in CTRL (p<0.01). _x000D_ Urea was only available for the T-group and decreased from 47.5±12.0 to 31.7±12.9 mg/dL (p<0.0001)._x000D_ Glomerular filtration rate (GFR) increased from 86.6±12.8 to 98.5±8.6 mL/min/1.73 m2 in the T-group and decreased from 90.8±20.2 to 87.0±26.0 mL/min/1.73 m2 in CTRL (p<0.0001 for both)._x000D_ γ-GT decreased from 39.31±11.62 to 28.95±7.57 U/L in the T-group (p<0.0001) and increased from 37.79±29.55 to 39.5±26.71 U/L in CTRL (p<0.0005)._x000D_ Bilirubin decreased from 1.64±4.13 to 1.21±1.89 mg/dL in the T-group (p<0.05) and increased from 1.04±7.08 to 1.12±1.96 mg/dL in CTRL (NS). _x000D_ AST remained stable in both groups, ALT declined slightly in both groups._x000D_ Medication adherence in the T-group was 100 per cent as all injections were administered in the office and documented._x000D_ There were 25 deaths (7.8%) in the T-group of which 11 (44%) were cardiovascular. In CTRL, 28 patients (15.2%) died, and all deaths (100%) were attributed to cardiovascular causes. _x000D_

Conclusions

Long-term TTh with TU in an unselected hypogonadal men resulted in improvement of renal function, whereas there was a slight worsening in untreated controls. Since renal function may be related to cardiovascular risk, the observed changes may have contributed to a reduction in mortality.

Funding

none

Authors
Aksam Yassin
Dany-Jan Yassin
Gheorge Doros
Abdulmaged Traish
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