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Title: Testosterone treatment in older men: clinical implications and unresolved questions from the Testosterone Trials.
Austin Authors: Yeap, Bu B;Page, Stephanie T;Grossmann, Mathis 
Affiliation: Department of Endocrinology and Diabetes, Fiona Stanley Hospital, Perth, WA, Australia
School of Medicine, University of Western Australia, Perth, WA, Australia
Division of Metabolism and Endocrinology, University of Washington, Seattle, WA, USA
Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
Department of Endocrinology, Austin Health, Heidelberg, Victoria, Australia
Issue Date: Aug-2018 2018-07-17
Publication information: The lancet. Diabetes & endocrinology 2018; 6(8): 659-672
Abstract: A decrease in the concentration of circulating testosterone in many older men is a biomarker and possibly a rectifiable contributing factor to ill health. Low circulating testosterone concentration has been associated with cardiovascular disease, reduced cognition, fracture risk, and anaemia. However, randomised placebo-controlled trials are essential to clarify the benefits and possible risks of testosterone treatment in men without hypothalamic, pituitary, or testicular disease. The Testosterone Trials (T-Trials) were a coordinated set of trials that, following a screening-to-enrolment ratio of 65:1, randomly assigned 790 men aged 65 years or older who had a baseline testosterone concentration of less than 9·54 nmol/L and symptoms consistent with hypogonadism, but no recognisable hypothalamic-pituitary-testicular axis pathology, to daily transdermal testosterone or placebo for 12 months. In the main trial, testosterone treatment resulted in a modest benefit for sexual function, whereas the other primary outcomes of vitality and physical function were not met. Data from concomitant substudies raised a possible concern over changes in coronary plaque volume, showed a neutral effect on memory and other cognitive functions, and revealed improvements in volumetric bone mineral density and anaemia. Although insufficient to alter the existing clinical equipoise, the T-Trials provided substantial new data on organ-specific outcomes for testosterone treatment in older men. Further clinical trials are necessary to determine whether testosterone treatment will translate into patient-valued health outcomes and to clarify effects on the cardiovascular system.
DOI: 10.1016/S2213-8587(17)30416-3
ORCID: 0000-0001-8261-3457
Journal: The lancet. Diabetes & endocrinology
PubMed URL: 30017800
Type: Journal Article
Appears in Collections:Journal articles

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