Is testosterone replacement therapy (TRT) appropriate in elderly men with hypogonadism?

From the Guidelines

Testosterone replacement therapy in elderly men is only recommended for those with documented low testosterone levels and symptoms of hypogonadism, specifically sexual dysfunction, as stated by the American College of Physicians 1.

Key Considerations

• The decision to initiate testosterone treatment should be based on a discussion between the clinician and patient about the potential benefits, harms, costs, and patient's preferences, as suggested by the American College of Physicians 1.
• Treatment should be reevaluated within 12 months and periodically thereafter, with discontinuation if there is no improvement in sexual function, as recommended by the American College of Physicians 1.
• Intramuscular formulations are considered a cost-effective option compared to transdermal formulations, with similar clinical effectiveness and harms, as noted by the American College of Physicians 1.

Important Evidence

• A systematic review by the American College of Physicians found that testosterone therapy may provide small improvements in sexual functioning and quality of life in older men with low testosterone levels, but little to no benefit for other common symptoms of aging, as reported by 1.
• The review also highlighted the lack of long-term efficacy and safety data for testosterone treatment in this population, as mentioned in 1.

Clinical Implications

• Clinicians should not initiate testosterone treatment in men with age-related low testosterone to improve energy, vitality, physical function, or cognition, as stated by the American College of Physicians 1.
• The potential benefits and risks of testosterone replacement therapy, including improved sexual function, increased muscle mass, and enhanced bone density, as well as risks such as polycythemia and potential cardiovascular effects, should be carefully considered and individualized for each patient, as discussed in 1.

From the FDA Drug Label

Limitations of use: • Safety and efficacy of testosterone gel 1.62% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. The FDA drug label does not answer the question.

From the Research

Testosterone Replacement Therapy in Elderly Men

• Testosterone replacement therapy (TRT) may be beneficial for elderly men with low testosterone levels and symptoms of hypogonadism, such as improved libido and sexual function, bone density, muscle mass, and mood 2, 3, 4.
• However, the risk-benefit ratio of TRT in older men is debatable, and it should be offered only to symptomatic men with confirmed low testosterone concentrations after explaining the uncertainties regarding the long-term safety of this treatment 2.
• TRT may be considered for men with severe hypogonadism and erectile dysfunction, severe insulin resistance or pre-diabetes mellitus, osteoporosis, or persistent mild depressive symptoms and/or low self-perceived quality of life, combined with standard medical care for each condition 2.
• Contraindications for TRT in elderly men include hypogonadal men actively seeking fertility treatment, older, frail men with known breast cancer or untreated prostate cancer, and those with severe or decompensated heart failure, or who have had myocardial infarction or stroke within the last four months 2.
• The quality of evidence regarding patients with previous prostate cancer or cardiovascular disease is too low to draw definitive conclusions, and any limits on duration of use are arbitrary, with treatment continuing for as long as the benefits outweigh the risks for the individual 2, 3, 5.
• Monitoring of older men on TRT should include assessment of clinical response, measurement of total testosterone, haematocrit, and prostate-specific antigen (PSA) concentrations, and bone density and/or quality, at regular intervals 2.