Testosterone Treatment With Long-Acting Testosterone Undecanoate in Men with Late-Onset Hypogonadism and the Metabolic Syndrome Reduced Serum Levels of Interleukin-6, Tumor Necrosis Factor alpha and C-Reactive Protein
Tishova, Y(1); Mskhalaya, G(1); Saad, F(2, 3); Kalinchenko, S(1)
(1)Research Center for Endocrinology, Dpt. of Andrology, FSA Rosmedtechnologiy, Moscow (2)Male Healthcare, Bayer Schering Pharma, Berlin (3)Research Dept., Gulf Medical College School of Medicine, Ajman
Objective: To study the effect of testosterone treatment on pro-inflammatory markers in hypogonadal men with the metabolic syndrome. Methods: 20 men with late-onset hypogonadism (total testosterone <11 nmol/l) and a positive diagnosis for the metabolic syndrome (made according to the IDF criteria), were randomized to receive 3 injections of either testosterone undecanoate (Nebido) or placebo according to the standard scheme. 12 weeks after the third injection of Nebido or placebo, patients were divided into two groups according to their serum level of total testosterone: Group 1 (n=13) total testosterone = 15.75 [13.5-17.3] nmol/l, Group 2 (n=7) total testosterone = 8.3 [6.5-10.2] nmol/l), and serum levels of interleukin-6 (IL-6), C-reactive protein (CRP) and tumor necrosis factor (TNF) alpha were measured at 30 weeks and compared to values measured at baseline. Statistical analysis was performed using the Wilcoxon test. Results: Results are expressed as median and interquartile range [25%;75%]. In patients in Group 1, IL-6 decreased from 4.6 [3.0-4.8] to 3.8 [2.8-4.0] pg/ml (normal range (NR) < 4.1 pg/ml) (р=0.04), TNFalpha decreased from 15.2 [12.3-15.3] to 12.2 [10.7-13.0] pg/ml (NR 0 - 8.21 pg/ml) (р=0.005) and CRP decreased from 3.8 [1.4-4.1] to 1.9 [0.6-3.1] mg/l (NR 0 - 5 mg/l) (р=0.01) from baseline to week 30. In patients in Group 2, there were no significant changes in IL-6, TNFalpha or CRP: IL-6 was 3.2 [2.8-3.2] and 3.2 [2.7-3.3] pg/ml, TNFalpha was 13.2 [12.1-13.9] and 12.0 [11.5-12.1] pg/ml) and CRP was 4.0 [0.6-6] and 4.9 [0.7-8.5] mg/L at baseline and week 30 respectively. Conclusion: Testosterone treatment with long-acting testosterone undecanoate (Nebido) in men with late onset hypogonadism and the metabolic syndrome, results in a reduction in serum levels of the pro-inflammatory markers IL-6, TNFalpha and CRP.
