Mp85-16 Extracorporeal Shock-Wave Therapy (Eswt) in Treatment of Ed: Results of Sham-Controlled Study

Abstract

Registry data of max. 9 years comprising 650 patients with hypogonadism including 266 men with primary (mean age 34.0 AE 11.7 years), 196 with secondary (mean age 31.9 AE 12.0 years) and 188 with functional hypogonadism (mean age 42.3 AE 11.3 years) all receiving uniform treatment using intramuscular T undecanoate (1000 mg). RESULTS: The registry contained 8358 time points with a subset of metabolic and safety parameters. Serum T concentrations increased from 5.7 AE 2.3 nmol/L to 19.4 AE 2.8 nmol/L in men with classical hypogonadism and from 7.8 AE 2.4 nmol/L to 19.2 AE 3.1 nmol/L in men with functional hypogonadism (difference in delta T: p<0.0001). There was an initial difference in the distribution of body mass index (BMI): 35.6% of men with classical hypogonadism and 51.6% of men with functional hypogonadism were obese (BMI>30 kg/m2, p¼0.0006).Changes over time using Kaplan-Meier models revealed fundamental differences in inter-individual effects: men with functional hypogonadism were more likely to lose 10% weight and 5% of waist circumference (WC) than men with classical hypogonadism (hazard ratio 1.3 [1.1-1.4], p¼0.008 and hazard ratio 1.4 [1.3-1.5], p¼0.001). There was no difference for increase in hematocrit. Changes in PSA levels were more likely to occur in functional hypogonadism (hazard ratio 1.3 [1.1-1.6], p¼0.003). Significantly more pronounced effects of T therapy in functional hypogonadism could also be attributed to changes in parameters of lipid (levels of total cholesterol, triglycerides, LDL-and HDL-cholesterol) and glucose metabolism. Stepwise multiple Cox regression models could attribute these differences to the initial higher values in BMI, WC, lipids, glucose and age found in functional hypogonadism. The condition as such rather attenuated the effects of T therapy compared to those seen in classical hypogonadism, due to the lower increase of T concentrations during treatment. CONCLUSIONS: This study provided major new findings regarding effects and safety of T therapy in different groups of hypogonadal men. Effects on factors influencing cardiovascular health are modulated by diagnosis and age. Patients with functional hypogonadism may experience greater benefits from T therapy; this being a function of their initially worse status in cardiovascular risk factors compared to men with classical forms of hypogonadism.