Rationale and evidence
Rationale
Hypogonadism justifying testosterone therapy regardless of age is confirmed based on measurement of circulating testosterone, luteinising hormone (LH) and follicle-stimulating hormone (FSH) concentrations. There is limited high-quality evidence to justify testosterone treatment in older men, usually with chronic disease, who have low circulating testosterone levels but without confirmed pathological hypogonadism, whether due to hypothalamic, pituitary or testicular disease.
Moreover, excess cardiovascular events have been associated with testosterone treatment of older men without pathological hypogonadism. While the evidence on these side effects is mixed and additional studies are needed to clarify whether testosterone therapy increases cardiovascular risk, this provides an added reason to restrict the prescription of testosterone therapy to confirmed cases of hypogonadism.
Evidence
Calof OM, Singh AB, Lee ML, et al. Adverse events associated with testosterone replacement in middle-aged and older men: a meta-analysis of randomized, placebo-controlled trials. J Gerontol A Biol Sci Med Sci. 2005;60(11): 1451-7.
Corona G, Maseroli E, Rastrelli G, et al. Cardiovascular risk associated with testosterone-boosting medications: a systematic review and meta-analysis. Expert Opin Drug Saf. 2014;13(10): 1327-5.
Finkle WD, Greenland S2, Ridgeway GK, et al. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One. 2014 29;9(1): e85805.
Xu L, Freeman G, Cowling BJ, Schooling CM. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials. BMC Med. 2013 Apr 18;11: 108.
Yeap BB, Grossmann M, McLachlan RI, et al. Endocrine Society of Australia position statement on male hypogonadism (part 1): assessment and indications for testosterone therapy. Med J Aust. 2016;15;205: 173-8.
Yeap BB, Grossmann M, McLachlan RI, et al. Endocrine Society of Australia position statement on male hypogonadism (part 2): treatment and therapeutic considerations. Med J Aust. 2016;205: 228-31.