Updated guidance on the diagnosis and treatment of hypogonadism: focus on the European Association of Urology (EAU) guidelines 2012
Guidelines on male hypogonadism. Dohle GR, Arver S, Bettocchi C, et al. European Association of Urology 2012. Feb:1−28.
ISA, ISSAM, EAU, EAA and ASA recommendations: Investigation, treatment and monitoring of late-onset hypogonadism in males. The Aging Male 2009;12:5−12.
Testosterone therapy in men with androgen deficiency syndromes: An Endocrine Society Clinical Practice Guideline. Bahsin S, Cunningham GR, Hayes FJ, et al. J Clin Endocrinol Metab 2010;95:2536– 2559.
This editorial focuses on the conclusions and recommendations of the Guidelines on Male Hypogonadism recently published by the European Association of Urology (EAU) in 2012.1 Conclusions and recommendations in these guidelines are compared to those presented in earlier guidelines published by the International Society for the Study of the Aging Male (ISSAM, 2009) and Endocrine Society (2010).2,3
What is known
The incidence of androgen deficiency in middle-aged men has been reported as 6%.4 The association between advancing age and declining levels of testosterone is well known5,6 and is an area of active research. In light of this, guidelines from several societies have been published over the past decade that offer recommendations and gand present in men with normal levels of testosteroneuidance for the treatment and diagnosis of male hypogonadism.1-3 The recommendations within guidelines are commonly categorized according to the strength of scientific evidence; providing transparency between the supporting evidence and recommendation given. In the absence of trials data, guidelines are able to provide suggestions based on clinical experience of respected authorities. With the continued publication of trial data in male hypogonadism, guidelines are updated regularly.
What these studies add
Guidelines published by EAU in 20121 expand on existing suggestions and recommendations given in guidelines published by ISSAM (2009)2 and Endocrine Society (2010).3 The recent EAU guidelines provide an updated definition for LOH, and include additional clinical symptoms and signs suggestive of hypogonadism in patients with low levels of testosterone.4,7 Many of these symptoms are associated with normal aging and present in men with normal levels of testosterone.5 It is suggested that clinicians measure serum testosterone levels in patients with one or more clinical symptoms. Following evaluation of data from three large community-based samples, Bhasin et al. suggest a cut-off value of 12.1 nmol/L for the lower normal level of testosterone.8 Although a consensus on a specific value has not been reached, the EAU 2012 guidelines highlight a range of 8–12 nmol/L for the lower normal range.1 Patients with levels of testosterone below this value have an increased risk of symptoms of androgen deficiency and adverse health outcomes. Hypogonadism may not always present as low testosterone levels, such as in men with primary testicular damage. As a result, levels of luteinizing hormone should also be considered.
Low levels of testosterone are associated with a number of chronic diseases, and patients may benefit from testosterone treatment. The conclusions drawn from EAU 2012 guidelines are supported by evidence obtained from well-designed controlled studies without randomization. The positive effect of testosterone treatment on body composition in hypogonadal men are presented in EAU guidelines, with an increase in lean body mass and decrease in fat mass.9 The beneficial effects of 3-months treatment with testosterone on trunk and waist fat, body weight, body mass index and lipid profile are also reported.10,11 Testosterone treatment has also demonstrated a positive effect on glycemic and lipid profiles, and a consequent decrease in cardiovascular risk.12
Evidence of potential risks of testosterone treatment in various diseases are presented in EAU guidelines, and recommendations are suggested to clinicians. The EAU guidelines conclude that testosterone therapy is not related to the development of cardiovascular events. This decrease in risk is supported by meta-analysis of randomized trials.13,14,15 For patients at low-risk of recurrent prostate cancer (and with no evidence of active disease) testosterone therapy can be cautiously considered not before 1 year of follow-up.16-18 However, this treatment remains off-label.16,17