Testosterone not linked to lasting benefit for older men without pathological hypogonadism
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Key takeaways:
- The proportion of men who reported benefits 5 years after the T4DM trial was similar in the testosterone and placebo groups.
- Testosterone replacement therapy continued after the study for 4.5% of participants.
Testosterone undecanoate therapy may not confer long-term benefits for men with impaired glucose tolerance and normal testosterone levels, according to a follow-up survey of participants in the T4DM trial.
In a study published in The Journal of Clinical Endocrinology & Metabolism, researchers surveyed men who participated in T4DM a median 5.1 years after the trial concluded. The percentage of men who said they experienced benefits from the therapy they received during the study was higher among those randomly assigned to testosterone undecanoate compared with placebo. However, there was no difference between the two groups in the proportion of men reporting benefits after the study.
“This was a pharmacological testosterone treatment with a short-term objective (improved glycemia) but no long-term benefits, so it should deter the prevailing overuse of testosterone prescribing other than for the sole valid indication, men with pathological hypogonadism,” David Handelsman, MBBS, PhD, FRACP, FAHMS, professor of reproductive endocrinology and andrology, and head of the andrology department at Concord Hospital, University of Sydney, told Healio.
The T4DM study was a multicenter, double-blind, randomized controlled trial in which 1,007 men aged 50 to 74 years with IGT or newly diagnosed diabetes, but no pathological hypogonadism, were randomly assigned to 1,000 mg testosterone undecanoate (Reandron, Bayer) or matching placebo every 3 months for 2 years. All participants in the study were invited to complete an online questionnaire. The survey was completed a median 5.1 years after the last study injection.
There were 316 men who received testosterone undecanoate and 283 who received placebo that completed the survey. A higher percentage of men said they experienced study benefits during the study in the testosterone group compared with placebo (64% vs. 49%; P < .001). After the study, the proportion of men experiencing benefits was similar between the two groups. Of those who completed the follow-up study, 34% were not aware of their treatment, 31% believed they were treated with testosterone and 36% believed they were treated with placebo.
After the study, 4.5% of men continued to use testosterone therapy prescribed by a provider who was not involved with the study. Testosterone replacement was prescribed at a higher rate among men who had been randomly assigned testosterone undecanoate in T4DM compared with placebo (6% vs. 2.8%; P = .03).
“The confirmation of androgen dependence in a small but statistically significant number of testosterone-treated men was important and not widely expected in the prevailing environment where testosterone is massively overprescribed often without proper evidence-based indications,” Handelsman said.
In the follow-up survey, there were no differences in self-reported diabetes diagnoses, diabetes drug treatments, prostate disease or cardiovascular disease between the testosterone and placebo groups. During T4DM, the testosterone group had a higher percentage of participants diagnosed with sleep apnea compared with placebo. However, sleep apnea diagnoses were similar between the two groups in the follow-up survey. Weight trajectories and attempts to lose weight during the follow-up period were similar between the two groups.
Handelsman said future research is needed to better understand the mechanism by which testosterone lowers oral glucose tolerance test values, but not HbA1c, as it could help to identify a molecular mechanism for reducing hyperglycemia.
For more information:
David Handelsman, MBBS, PhD, FRACP, FAHMS, can be reached at djh@sydney.edu.au.
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