Endocrine Abstracts (2012) 29 P1021

Side effect profile of long-term treatment of hypogonadal men with testosterone undecanoate

F. Saad1,2, A. Haider3 & L. Gooren4

1Bayer Pharma AG, Berlin, Germany; 2Gulf Medical University, Ajman, United Arab Emirates; 3Private Practice, Bremerhaven, Germany; 4VUMC Amsterdam, Amsterdam, The Netherlands.

Introduction: Testosterone therapy for hypogonadal men has been used for decades. However, there are still concerns regarding the safety of this treatment, particularly in elderly men.

Methods: Prospective registry study of 252 men (mean age 60.6±8.0 years), with testosterone levels between ≤3.5 ng/ml. They received parenteral testosterone undecanoate 1000 mg at day 1, week 6 and every 12 weeks thereafter for up to 66 months.

Results: After 60 months the following changes were observed.

Erythropoiesis: Haemoglobin increased from 14.44±0.72 to 14.99±0.45 g/dl (P<0.0001 vs baseline). Haematocrit increased from 43.18±2.83 to 48.78±1.7% (P<0.0001 vs baseline). Four patients had haematocrit levels >52% which resolved without intervention.

Prostate: PSA increased from 1.76±0.96 to 1.82±0.96 ng/ml (P<0.0001 vs baseline) with a plateau after 24 months. 3/255 patients were diagnosed with prostate cancer following elevated PSA at 18 weeks of treatment. Tumour grade was T2 in all three and Gleason score 3+3 in two and 3+2 in one patient, resp. They all underwent radical prostatectomy and were excluded from the analysis. Prostate volume increased from 28.3±11.12 to 30.23±12.4 ml (P<0.0001 vs baseline). The International Prostate Symptom score (IPSS) improved from 6.7±4.22 to 2.83±1.25. This was statistically significant vs baseline (P<0.0001) and the decrease remained statistically significant compared to the previous year over the first 48 months.

Liver enzymes: Aspartate transaminase (AST) decreased from 43.34±17.31 to 20.16±3.21 U/l, alanine transaminase (ALT) from 44.04±18.16 to 20.54±3.92 U/l (P<0.0001 vs baseline with a plateau after 24 months).

Conclusions: The incidence of 3/255 patients with prostate cancer is similar to that in screening programmes. Long-term treatment with testosterone undecanoate with monitoring according to the guidelines is acceptably safe.

Declaration of interest: I fully declare a conflict of interest. Details below.

Funding: This work was supported, however funding details unavailable.

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