February 17, 2016

expert reaction to study looking at testosterone treatment in older men with low testosterone

A group of scientists have published their work in the New England Journal of Medicine where they attempted to analyse the effect of raising testosterone levels in older men over the age of 65 with very low testosterone levels, and reported that this had a moderate benefit regarding sexual function and some benefit with regard to mood and depressive symptoms, but not with vitality.

Prof. Frederick Wu, Professor of Medicine and Endocrinology, University of Manchester, said:

“This is the most important and largest randomised trial of testosterone replacement to date in symptomatic older men (over 65 years of age) with unequivocally low testosterone (<9.5 nmol/L), also known as hypogonadism. It should be emphasised that is a relatively rare condition since only 1.5% of those screened (790 out of 51,085 men) were eligible to enroll in the trial. It’s also important to note that these findings do not apply to younger men with borderline low testosterone levels – this study did not look at such men.

“The results show clear benefits in these older men with very low testosterone on different aspects of sexual function and mood, but not on vitality. In a sub-analysis, there was some suggestions of an improvement in walking distance as well. Testosterone treatment was used for one year (compared to placebo) which increased levels to those typical in younger men (19 – 40 yr old). There was no increase in reported adverse effects compared to placebo.

“These results can address some of the concerns recently expressed by the US FDA cautioning the use of testosterone in elderly men due to lack of evidence of efficacy and safety, however this study does not have sufficient numbers of participants to address the longer–term safety of testosterone treatment in older men, so more research is needed. The new data provide support for the efficacy of testosterone treatment in older men with symptoms and low testosterone compatible with hypogonadism. Further results from this study will address other outcomes such as cognition and bone health.”

‘Effects of testosterone treatment in older men’ by P.J. Snyder et al. will be published in NEJM at 22:00 UK time on Wednesday 17 February 2016, which is also when the embargo will lift.

Declared interests

Prof. Frederick Wu: “Relevant to testosterone: I have acted as a consultant for Bayer-Schering, Eli Lilly and Besins Healthcare and also participated in advisory board meetings and lectured on their behalf. I have received lecture fees from Bayer-Schering and Besins Healthcare and received grant support (2010-2014) from Bayer Schering AG and Besins Healthcare.”